Description
Release form
Coated tablets
Packing
14 pcs.
Pharmacological action
Fromilide has an antibacterial, bacteriostatic, bactericidal effect.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to Fromilid: upper respiratory tract infections (acute and chronic tonsillopharyngitis, acute and chronic recurrent sinusitis, acute otitis media)
infections of the bronchial bronchitis, acute bronchitis community-acquired bacterial pneumonia, including pneumonia caused by atypical pathogens)
infections of the skin and soft tissues
infections caused by mycotic bacteria (Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium marinum, Mycobacterium leprae)
prophylaxis of the spread of infections caused by the Mycobacterium avium complex (MAC) in HIV-infected patients with CD4 lymphocytes (T-helper lymphocytes) not exceeding 100 in 1 mm3
eradication of Helicobacter pylori disease intestines or stomach (always in combination with other drugs).
Contraindications
Hypersensitivity to clarithromycin or other antibacterial drugs from the macrolide group or other components of sromlkp Fromilid severe liver failure
hepatitis, history of
porphyria srdlcomp pregnancy
children’s age up to 6 months (for the dosage form – granules for suspension for oral administration) – there is not enough experience relate no efficacy and safety of
children under 12 years old and / or weighing less than 33 kg (for a dosage form – tablets, film-coated)
congenital fructose intolerance, glucose / galactose malabsorption syndrome or a deficiency of the sucrose-isomaltase enzyme (only for the dosage form – granules for the preparation of an oral suspension).
Precautions: II-III trimesters of pregnancy, moderate and severe renal failure, liver failure.
Composition
1 tab. contains clarithromycin 500 mg, excipients: corn starch MCC (Avicel PH 101) MCC (Avicel PH 102) silicon dioxide colloidal anhydrous starch pregelatinized polacriline potassium talc magnesium stearate
Dosage and administration of
Fromilide is taken orally, swallowed whole, not broken, washed down with a small amount of liquid.
Adults and children over 12 years of age and / or body weight 33 kg Fromilide is usually prescribed 250 mg every 12 hours. For the treatment of acute sinusitis, severe infections and when the infection is caused by Haemophilus influenzae, 500 mg clarithromycin is prescribed every 12 hours The course of treatment is 7-14 days.
Children under the age of 12 years and / or weighing less than 33 kg are usually prescribed a suspension of Fromilid at a dose of 15 mg / kg / day, divided into 2 doses. It is recommended to give a little liquid after taking the suspension. The maximum daily dose is 2 g.
Side effects of the digestive system: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, short-term discoloration of the teeth and tongue, pancreatitis, pseudomembranous enterocolitis, cholestatic jaundice, hepatitis. Impaired liver function can be severe, but usually reversible. Cases of liver failure and death have been very rarely observed, mainly against the background of severe concomitant diseases and / or concomitant drug therapy.
From the central and peripheral nervous system: headache, vertigo, paresthesia, drowsiness, hallucinations, convulsions, psychosis, dizziness, confusion, fear, insomnia, nightmares, depersonalization, disorientation.
From the hemopoietic organs and lymphatic system: leukopenia, thrombocytopenia.
On the part of the sensory organs: a change in taste (dysgeusia), olfactory ringing in the ears, short-term hearing loss that occurs after drug withdrawal.
From the cardiovascular system: prolongation of the QT interval on the ECG, ventricular tachycardia of the pirouette type (torsades de pointes).
From the respiratory system: shortness of breath.
From the musculoskeletal system: arthralgia, myalgia.
From the genitourinary system: interstitial nephritis, renal failure.
Allergic reactions: skin rash, urticaria, pruritus, facial swelling, anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), Quincke’s angioedema.
Storage conditions
In the dark place at a temperature of no higher than 20 ° C.
Active ingredient
Clarithromycin
Dosage form
tablet
Appointment
Pregnant II and III trimester by doctor’s appointment, Adult by doctor’s appointment, Children over 12 years of age, Children by doctor’s appointment
Indications
From skin infections, From projections of the respiratory tract, from stomach ulcers and 12 duodenal ulcer, from otitis media, sinusitis, from gastrointestinal infections caused by Helicobacter pylori, from pharyngitis, a sore throat, from tonsillitis, pneumonia, Bronchitis
KRKA d.d. Novo mesto AO, Slovenia
